Orthotics is the branch of medical and mechanical sciences dealing with bracing and straightening weak or ineffective joints or muscles by the use of braces or supports. Orthotic devices are typically worn by individuals with physical limitations that have been acquired or that are congenital and are particularly worn by those individuals with physical limitations arising from neurological disorders occurring from cerebral palsy, multiple sclerosis, cerebral vascular accidents, club foot, spinabifida, and the like. In cases involving the leg or foot, treatment often involves the custom manufacture of orthotic devices which are worn either attached to or inside a patient's shoe and which extend upwardly on the outer surface of the calf and typically, over the patient's clothing. These devices help minimize physical discomfort for patients suffering from structural and/or physical deficiencies in their feet or legs.
In many instances, persons suffering with the above neurological disorders often develop marked deformities in the lower and upper extremities. In many instances the lower extremity deformity that results is classified as Spastic Equinovarus. Spasticity and its accompanying deformity of the lower limb severely reduces the ambulatory capacity of the individuals suffering from these disorders. Moreover, the deformity of the foot/ankle complex has traditionally been the most difficult to correct via orthotic devices, physical medicine, surgical intervention and medications.
The use of orthotic devices to help support and control joints of the lower extremities is an extremely important part of medical rehabilitation. Despite this importance, however, the development of lower extremity orthotic devices has experienced few major breakthroughs. For example, traditional orthotic devices consisting of metallic supports and leather and/or fabric straps are awkward and cumbersome, particularly for patients with generalized motor weakness. Most of these devices are heavy, unattractive and must be permanently attached to the wearer's shoes. Furthermore, these devices tend to cause damage to clothing due to frictional wear, rough edges and pinching joints.
Key to any therapeutic endeavor is patient compliance with the prescribed therapy. This is particularly true with orthotic devices which achieve their benefits only after they are properly and consistently worn over an extended period of time. With younger patients, and especially those children afflicted with cerebral palsy, the physical challenges associated with the disorder are often over shadowed by the psychological trauma of wearing the prescribed orthotic. In many instances a child must not only bear the burden of the physical handicap, but the stigma of having to wear an orthotic device; devices which call attention not only to the disorder of the individual but, more often, to the apparatus itself. The orthotics of the past were particularly egregious in this regard and in many cases patients would either forego wearing the prescribed orthotic or would preferentially engage in physical activities which did not require wearing the orthotic. The net result is, of course, that the orthotic cannot perform its intended function, and the patient realizes little or no appreciable benefit from a device which is under-utilized.
In the past two decades, new materials, particularly plastics and composite materials have become recognized as generally suitable replacements for the steel, aluminum and other metals formerly used to construct orthotic devices. Moreover, the use of these materials in orthotics allowed orthotists to consider new design concepts, resulting in lighter, less cumbersome and slightly more visually acceptable devices. For example, research at the Texas Institute for Rehabilitation and Research by Engen lead to the development of a molded polypropylene ankle-foot orthotic device (AFO) which is worn inside the shoe. This AFO eliminated the mechanical ankle joint and brace shoe attachment of conventional braces and allowed the user freedom to wear the device with his or her own shoe (Engen, Orthotics and Prosthetics 26 (4):1-5 1972).
Other plastic and plastic/composite orthotic therapeutic devices are also known. For example, U.S. Pat. No. 4,554,912 to Haberman is directed to a plastic orthotic therapeutic device for the treatment of varus or foot inversion and equinus or foot drop. The orthotic is made up of light weight, hygienic polypropylene and may be worn inside the patient's shoe.
U.S. Pat. No. 4,446,856 to Jordan also relates to a orthotic device which includes a boot for immobilizing the ankle and foot and holding the ankle and foot in a neutral position of maximal joint concurrency.
U.S. Pat. No. 5,121,742 to Engen relates to a lower extremity orthotic device including thermoplastic inner and outer side members in a thermoplastic ankle-foot orthotic member for a standing frame lower extremity orthotic apparatus.
While plastic orthotics have certain advantages in that they are often lighter in weight, less cumbersome, are mass manufacturable and are modifiable after fabrication to ensure proper fit, a drawback of orthotics in general, and even with respect to the plastic orthotics is the lack of any cosmetic appeal. In short, orthotic devices are generally unattractive; so much so that they cause attention to be drawn to the disability of the wearer rather than his or her abilities.
From the foregoing, it can be seen that it would be advantageous to provide an orthotic device which may be made more cosmetically appealing while still providing the beneficial effects associated with its use. It can also be seen that it would be desirable to provide an orthotic device which can be fabricated using readily available technologies. Finally, it will be appreciated that it would be desirable to provide an orthotic device which would allow the wearer the opportunity to express his or her own stylistic preferences or which may be adapted to suit the wearer's fashion needs.
It is an object of the present invention to provide a comfortable, effective and cosmetically appealing orthosis.
It is another object of the present invention to provide a lightweight, plastic, laminated orthosis which has a visible indicia bearing layer.
It is yet another object of the present invention to provide an orthosis which may bear a variety of indicia and which may be fabricated using currently available technologies.
It is still another object of the present invention to provide a cosmetically appealing orthosis which may be easily and inexpensively fabricated.